Fiber Optic Enabled Deployable Medical Devices for Monitoring, Assessment and Capture of Deployment Information

ABSTRACT

Disclosed herein is a system, apparatus and method directed to placing a medical instrument in a vasculature of a patient body. The optical fiber includes one or more core fibers. The system also includes a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing an incident light signal to the optical fiber, where the optical fiber is coupled to a deployable medical device, receiving a reflected light signal of the incident light, and processing the reflected light signal to determine deployment information pertaining to deployment of the deployable medical device. The medical device may be a balloon, a filter, a stent or a valve, and the deployment information may include a location of the deployment, a status of the deployment, measurements of the deployable medical device in a deployed state or a shape of the deployed medical device.

PRIORITY

This application claims the benefit of priority to U.S. PatentApplication No. 63/091,154, filed Oct. 13, 2020, which is incorporatedby reference in its entirety into this application.

BACKGROUND

In the past, certain intravascular guidance of medical devices, such asguidewires and catheters for example, have used fluoroscopic methods fortracking tips of the medical devices and determining whether distal tipsare appropriately localized in their target anatomical structures.However, such fluoroscopic methods expose patients and their attendingclinicians to harmful X-ray radiation. Moreover, in some cases, thepatients are exposed to potentially harmful contrast media needed forthe fluoroscopic methods.

More recently, electromagnetic tracking systems have been used involvingstylets. Generally, electromagnetic tracking systems feature threecomponents: a field generator, a sensor unit and control unit. The fieldgenerator uses several coils to generate a position-varying magneticfield, which is used to establish a coordinate space. Attached to thestylet, such as near a distal end (tip) of the stylet for example, thesensor unit includes small coils in which current is induced via themagnetic field. Based on the electrical properties of each coil, theposition and orientation of the medical device may be determined withinthe coordinate space. The control unit controls the field generator andcaptures data from the sensor unit.

Although electromagnetic tracking systems avoid line-of-sight reliancein tracking the tip of a stylet while obviating radiation exposure andpotentially harmful contrast media associated with fluoroscopic methods,electromagnetic tracking systems are prone to interference. Morespecifically, since electromagnetic tracking systems depend on themeasurement of magnetic fields produced by the field generator, thesesystems are subject to electromagnetic field interference, which may becaused by the presence of many different types of consumer electronicssuch as cellular telephones. Additionally, electromagnetic trackingsystems are subject to signal drop out, depend on an external sensor,and are defined to a limited depth range.

Disclosed herein is a system including a deployable medical device and amedical instrument, where an optical fiber may be detatchably integratedinto or coupled to the deployable medical device and where the opticalfiber may be removably disposed in the medical instrument. Additionally,methods are disclosed including performance of obtaining reflectedoptical signals from a distal end of the optical fiber where thereflected optical signals indicate a shape and/or status of thedeployable medical device.

SUMMARY

Briefly summarized, embodiments disclosed herein are directed tosystems, apparatus and methods for obtaining oximetry data (such asoxygen level) and, optionally, three-dimensional (3D) information(reflected light) corresponding to a trajectory and/or shape of amedical instrument, such as a catheter, a guidewire, or a stylet, via afiber optic core during advancement through a vasculature of a patient,and assisting in navigation of the medical instrument duringadvancement.

More particularly, in some embodiments, the medical instrument includesone or more optical fiber cores, where each are configured with an arrayof sensors (reflective gratings), which are spatially distributed over aprescribed length of the core fiber to generally sense external strainand temperature on those regions of the core fiber occupied by thesensor. Each optical fiber core is configured to receive light (e.g.,broadband light, infrared light, near infrared light, etc.) from aconsole during advancement through the vasculature of a patient, wherethe broadband light propagates along at least a partial distance of theoptical fiber core toward the distal end. For purposes of clarity, theterms incident light or broadband incident light may be utilized in thedescription below; however, infrared light and near infrared light maybe alternatively utilized. Given that each sensor positioned along theoptical fiber core is configured to reflect light of a different,specific spectral width, the array of sensors enables distributedmeasurements throughout the prescribed length of the medical instrument.These distributed measurements may include wavelength shifts having acorrelation with strain and/or temperature experienced by the sensor.

The reflected light from the sensors (reflective gratings) within anoptical fiber core is returned from the medical instrument forprocessing by the console. The physical state of the medical instrumentmay be ascertained based on analytics of the wavelength shifts of thereflected light. For example, the strain caused through bending of themedical instrument and hence angular modification of the optical fibercore, causes different degrees of deformation. The different degrees ofdeformation alter the shape of the sensors (reflective grating)positioned on the optical fiber core, which may cause variations(shifts) in the wavelength of the reflected light from the sensorspositioned on the optical fiber core. The optical fiber core maycomprise a single optical fiber, or a plurality of optical fibers (inwhich case, the optical fiber core is referred to as a “multi-coreoptical fiber”).

As used herein, the term “core fiber,” generally refers to a singleoptical fiber core disposed within a medical device. Thus, discussion ofa core fiber refers to single optical fiber core and discussion of amulti-core optical fiber refers to a plurality of core fibers. Variousembodiments discussed below to detection of the health (and particularlythe damage) that occurs in each of an optical fiber core of medicalinstrument including (i) a single core fiber, and (ii) a plurality ofcore fibers. It is noted that in addition to strain altering the shapeof a sensor, ambient temperature variations may also alter the shape ofa sensor, thereby causing variations (shifts) in the wavelength of thereflected light from the sensors positioned on the optical fiber core.

The deployment or placement of a deployable medical device within apatient body may currently be visualized and monitored using large,complex and expensive equipment. For instance, such visualization andmonitoring may be performed through the use of magnetic resonanceimaging (MRI), which applicable equipment typically costing upwards of$150,000, with some available MRI machines costing over $300,000. Inaddition to being extremely expensive, MRI machines are typically large,immobile structures that have a history of inducing claustrophobia insome patients. Further, due to the use of a strong magnet, the MRIprocess cannot be performed on patients with implanted pacemakers.

In light of the above, embodiments of the disclosure seek to cure suchproblems with the current state of the art enabling visualization andmonitoring of deployment or placement of a deployable medical devicewithin a patient body. For instance, systems disclosed herein may beconfigured to utilize an optical fiber to provide information to aclinician regarding the deployment of a deployable medical device.Examples of a deployable medical device may include, but are not limitedor restricted to, a balloon, a stent, an implantable valve, a clotfilter, a coil, etc. In particular, systems of the disclosure mayinclude a medical instrument that is configurated to advance within thevasculature of a patient body, where a deployable medical device mayextend from a distal end of the medical instrument. Further, an opticalfiber may also extend along the length of the medical instrument and becoupled to the deployable medical device such that the optical fibermeasures strain asserted on the optical fiber by the deployment of themedical device.

As discussed herein, based on the type and degree of strain asserted onthe optical fiber, sensors disposed along the length of the opticalfiber may alter (shift) the wavelength of light reflected by the sensorsto convey the type and degree of stain on the optical fiber at thelocation occupied by each sensor. Thus, systems disclosed herein obtaininformation pertaining to the deployment of the medical device throughdetection of strain asserted on the optical fiber during deployment. Forexample, such information may indicate a location of the deployment, astatus of the deployment, measurements of the medical device in itsdeployed state, and/or a shape of the deployed medical device(collectively, “deployment information”).

A few non-limiting examples will now be briefly discussed, some of whichwill be described in further detail below. In some embodiments, themedical instrument may comprise a catheter and the deployable medicaldevice may comprise an inflatable balloon that extends from a distal endof the catheter. In such an embodiment, an optical fiber may extendalong the length of the catheter and be coupled to the balloon in one ofvarious configurations. When the balloon is deployed (i.e., inflated),strain is asserted on the optical fiber and the sensors of the opticalfiber detect such strain. Concurrently, a console coupled to a proximalend of each of the catheter and the optical fiber transmits an incidentlight signal, which propagates distally along the optical fiber towardthe balloon. The sensors of the optical fiber reflect light havingcertain wavelengths back to the console indicating the strain detectedby the sensors. Based on the reflected light, logic of the consoledetermines deployment information.

In some embodiments, the medical instrument may comprise a combinationof a catheter and an inflatable balloon, where the balloon extends fromthe distal end of the catheter and the deployable medical device may bea stent. The stent may surround the balloon during advancement through apatient vasculature. Further, an optical fiber may extend along thelength of the catheter and be detachably coupled to the stent. When theballoon is inflated in order to deploy the stent, strain is asserted onthe optical fiber and the sensors of the optical fiber detect suchstrain. Concurrently, a console coupled to a proximal end of each of thecatheter and the optical fiber transmits an incident light signal, whichpropagates distally along the optical fiber toward the balloon andstent. The sensors of the optical fiber reflect light having certainwavelengths back to the console indicating the strain detected by thesensors. Based on the reflected light, logic of the console determinesdeployment information. The optical fiber may be detached from the stentsuch that the stent may remain within the patient vasculature while thecatheter, the balloon and the optical fiber are withdrawn.

Similarly, in other embodiments, the medical instrument may comprise acombination of a catheter and an inflatable balloon, where the balloonextends from the distal end of the catheter and the deployable medicaldevice may be an implantable valve. Deployment information pertaining todeployment of the implantable valve is obtained in a similar manner asdiscussed above with respect to the stent.

In yet other embodiments, the medical instrument may comprise a catheterand the deployable medical device may comprise either a coil or afilter. Further, an optical fiber may extend along the length of thecatheter and be detachably coupled to either the coil or the filter.When either the coil or filter is deployed (e.g., released from thecatheter), strain is asserted on the optical fiber and the sensors ofthe optical fiber detect such strain. Deployment information pertainingto deployment of either the coil or the filter is obtained in a similarmanner as discussed above with respect to the stent.

Specific embodiments of the disclosure include utilization of a medicalinstrument, such as a stylet, featuring a multi-core optical fiber and aconductive medium that collectively operate for tracking placement witha body of a patient of the stylet or another medical device (such as acatheter) in which the stylet is disposed. In lieu of a stylet, aguidewire may be utilized. For convenience, embodiments are generallydiscussed where the optical fiber core is disposed within a stylet;however, the disclosure is not intended to be so limited as thefunctionality involving detection of the health of an optical fiber coredisclosed herein may be implemented regardless of the medical device inwhich the optical fiber core is disposed. In some embodiments, theoptical fiber core may be integrated directly into a wall of thecatheter.

In some embodiments, the optical fiber core of a stylet is configured toreturn information for use in identifying its physical state (e.g.,shape length, shape, and/or form) of (i) a portion of the stylet (e.g.,tip, segment of stylet, etc.) or a portion of a catheter inclusive of atleast a portion of the stylet (e.g., tip, segment of catheter, etc.) or(ii) the entirety or a substantial portion of the stylet or catheterwithin the body of a patient (hereinafter, described as the “physicalstate of the stylet” or the “physical state of the catheter”). Accordingto one embodiment of the disclosure, the returned information may beobtained from reflected light signals of different spectral widths,where each reflected light signal corresponds to a portion of broadbandincident light propagating along a core of the multi-core optical fiber(core fiber) that is reflected back over the core fiber by a particularsensor located on the core fiber. One illustrative example of thereturned information may pertain to a change in signal characteristicsof the reflected light signal returned from the sensor, where wavelengthshift is correlated to (mechanical) strain on the core fiber or adetected change in ambient temperature.

In some embodiments, the core fiber utilizes a plurality of sensors andeach sensor is configured to reflect a different spectral range of theincident light (e.g., different light frequency range). Based on thetype and degree of strain asserted on each core fiber, the sensorsassociated with that core fiber may alter (shift) the wavelength of thereflected light to convey the type and degree of stain on that corefiber at those locations of the stylet occupied by the sensors. Thesensors are spatially distributed at various locations of the core fiberbetween a proximal end and a distal end of the stylet so that shapesensing of the stylet may be conducted based on analytics of thewavelength shifts. Herein, the shape sensing functionality is pairedwith the ability to simultaneously pass an electrical signal through thesame member (stylet) through conductive medium included as part of thestylet.

Similarly, the sensors may alter (shift) the wavelength of the reflectedlight to convey sensed variations in ambient temperature. Thealterations in response to detected variations in ambient temperaturethereby provide for a temperature sensing functionality.

More specifically, in some embodiments each core fiber of the multi-coreoptical fiber is configured with an array of sensors, which arespatially distributed over a prescribed length of the core fiber togenerally sense external strain on or variations in ambient temperatureproximate those regions of the core fiber occupied by the sensor. Giventhat each sensor positioned along the same core fiber is configured toreflect light of a different, specific spectral width, the array ofsensors enables distributed measurements throughout the prescribedlength of the multi-core optical fiber. These distributed measurementsmay include wavelength shifts having a correlation with strainexperienced and/or temperature variations detected by the sensor.

In more detail, each sensor may operate as a reflective grating such asa fiber Bragg grating (FBG), namely an intrinsic sensor corresponding toa permanent, periodic refractive index change inscribed into the corefiber. Stated differently, the sensor operates as a light reflectivemirror for a specific spectral width (e.g., a specific wavelength orspecific range of wavelengths). As a result, as broadband incident lightis supplied by an optical light source and propagates through aparticular core fiber, upon reaching a first sensor of the distributedarray of sensors for that core fiber, light of a prescribed spectralwidth associated with the first sensor is reflected back to an opticalreceiver within a console, including a display and the optical lightsource. The remaining spectrum of the incident light continuespropagation through the core fiber toward a distal end of the stylet.The remaining spectrum of the incident light may encounter other sensorsfrom the distributed array of sensors, where each of these sensors isfabricated to reflect light with different specific spectral widths toprovide distributed measurements, as described above.

During operation, multiple light reflections (also referred to as“reflected light signals”) are returned to the console from each of theplurality of core fibers of the multi-core optical fiber. Each reflectedlight signal may be uniquely associated with a different spectral width.Information associated with the reflected light signals may be used todetermine a three-dimensional representation of the physical state ofthe stylet within the body of a patient through detection of strain.Herein, the core fibers are spatially separated with the cladding of themulti-mode optical fiber and each core fiber is configured to separatelyreturn light of different spectral widths (e.g., specific lightwavelength or a range of light wavelengths) reflected from thedistributed array of sensors fabricated in each of the core fibers.

During vasculature insertion and advancement of the catheter, theclinician may rely on the console to visualize a current physical state(e.g., shape) of a catheter guided by the stylet to avoid potential pathdeviations. As the periphery core fibers reside at spatially differentlocations within the cladding of the multi-mode optical fiber, changesin angular orientation (such as bending with respect to the center corefiber, etc.) of the stylet imposes different types (e.g., compression ortension) and degrees of strain on each of the periphery core fibers aswell as the center core fiber. The different types and/or degree ofstrain may cause the sensors of the core fibers to apply differentwavelength shifts, which can be measured to extrapolate the physicalstate of the stylet (catheter).

Further embodiments of the disclosure are directed to display screensthat may be generated based on the received reflected light. Forexample, following determination of deployment information obtained byprocessing and analyzing the reflected light, the deployment informationbe displayed for viewing by a clinician. Additionally, the shape sensingfunctionalities discussed herein may result in the determination of ashape of a catheter or other medical instrument during advancementthrough a patient vasculature and providing a correspondingvisualization. In addition to such a visualization, the system mayinclude logic that generates a display of the medical device as deployedwithin the patient vasculature. For instance, in combination with thelocation tracking and/or shape sensing functionalities discussed below,the logic of the console may determine a location of the deployment anda status of the deployment.

In particular, the optical fiber(s) coupled to the deployable medicaldevice may reflect light signals that indicates a positioning and/orshape of the medical device. The positioning and/or shape may refer towhether the medical device has expanded (e.g., whether a stent hasexpanded to have an expected diameter based on the vessel in which it isbeing deployed). As another example, the positioning and/or shape mayrefer to a shape of a coil deployed within an aneurysm, which mayindicate to a clinician that the coil has sufficiently become wound,twisted, looped, etc., within the aneurysm. Other embodiments andexamples are discussed below. Further, deployment information mayprovide information as to an operational state of the medical device(e.g., whether valve leaflets are properly opening and closing).

Each of the above embodiments may be displayed to assist the clinicianto confirm proper deployment. In some embodiments, visualizations of amedical device imposed within a patient body may be shown. In someembodiments, various metrics may be illustrated that are determinedbased on the reflected light. Some embodiments of these various metricsmay include, but are not limited or restricted to, a diameter of astent, timing of the opening/closing of a valve, diameter of a balloon,diameter of a valve, etc.

Embodiments of the disclosure may include a combination of one or moreof the methodologies to confirm that an optical fiber within a body ofimplementation (e.g., an introducer wire, a guidewire, a stylet within aneedle, a needle with fiber optic inlayed into the cannula, a styletconfigured for use with a catheter, an optical fiber between a needleand a catheter, and/or an optical fiber integrated into a catheter) islocated at a specified location with the vasculature based on oximetryreadings determined from light reflected from one or more sensorsdisposed at the distal tip of the optical fiber.

Some embodiments include a medical device system for inserting a medicalinstrument within a patient body, where the system comprises the medicalinstrument including an optical fiber having one or more of core fibers.The system may also include a console including one or more processorsand a non-transitory computer-readable medium having stored thereonlogic, when executed by the one or more processors, causes operationsincluding providing an incident light signal to the optical fiber, wherethe optical fiber is coupled to a deployable medical device, receiving areflected light signal of the incident light, and processing thereflected light signal to determine deployment information pertaining todeployment of the deployable medical device.

In some embodiments, each of the one or more core fibers includes aplurality of sensors distributed along a longitudinal length of acorresponding core fiber and each sensor of the plurality of sensors isconfigured to (i) reflect a light signal of a different spectral widthbased on received incident light, and (ii) change a characteristic ofthe reflected light signal for use in determining a physical state ofthe optical fiber. In some embodiments, the deployment informationincludes at least one of a location of the deployment, a status of thedeployment, measurements of the deployable medical device in a deployedstate or a shape of the deployed medical device.

In other embodiments, the optical fiber is a multi-core optical fiberincluding a plurality of core fibers, and wherein the incident lightpropagates along a first core fiber and the reflect light signalpropagates along a second core fiber. In yet some embodiments, thelogic, when executed by the one or more processors, causes furtheroperations including generating a visualization of representing thedeployable medical device within the patient body in a non-deployedstate and in a deployed state. In still some embodiments, the logic,when executed by the one or more processors, causes further operationsincluding generating a display indicating the location of the distal tipof the optical fiber within the patient body.

In some embodiments, the medical instrument is one of an introducerwire, a guidewire, a stylet, a stylet within a needle, a needle with theoptical fiber inlayed into a cannula of the needle or a catheter withthe optical fiber inlayed into one or more walls of the catheter. Insome embodiments, the medical device is one of a balloon, a filter, astent or a valve. In some particular embodiments when the medical deviceis a stent, the logic, when executed by the one or more processors,causes further operations including determining a diameter of the stentin a deployed state. In some embodiments, the optical fiber is disposedwithin a groove, channel or lumen of the medical device duringadvancement of the medical device within the patient body.

Other embodiments of the disclosure are directed to a method for placinga medical instrument into a body of a patient. The method includesproviding an incident light signal to the optical fiber, where theoptical fiber is coupled to a deployable medical device, receiving areflected light signal of the incident light, and processing thereflected light signal to determine deployment information pertaining todeployment of the deployable medical device.

In some embodiments, each of the one or more core fibers includes aplurality of sensors distributed along a longitudinal length of acorresponding core fiber and each sensor of the plurality of sensors isconfigured to (i) reflect a light signal of a different spectral widthbased on received incident light, and (ii) change a characteristic ofthe reflected light signal for use in determining a physical state ofthe optical fiber. In some embodiments, the deployment informationincludes at least one of a location of the deployment, a status of thedeployment, measurements of the deployable medical device in a deployedstate or a shape of the deployed medical device.

In other embodiments, the optical fiber is a multi-core optical fiberincluding a plurality of core fibers, and wherein the incident lightpropagates along a first core fiber and the reflect light signalpropagates along a second core fiber. In yet some embodiments, thelogic, when executed by the one or more processors, causes furtheroperations including generating a visualization of representing thedeployable medical device within the patient body in a non-deployedstate and in a deployed state. In still some embodiments, the logic,when executed by the one or more processors, causes further operationsincluding generating a display indicating the location of the distal tipof the optical fiber within the patient body.

In some embodiments, the medical instrument is one of an introducerwire, a guidewire, a stylet, a stylet within a needle, a needle with theoptical fiber inlayed into a cannula of the needle or a catheter withthe optical fiber inlayed into one or more walls of the catheter. Insome embodiments, the medical device is one of a balloon, a filter, astent or a valve. In some particular embodiments when the medical deviceis a stent, the logic, when executed by the one or more processors,causes further operations including determining a diameter of the stentin a deployed state. In some embodiments, the optical fiber is disposedwithin a groove, channel or lumen of the medical device duringadvancement of the medical device within the patient body.

Yet alternative embodiments of the disclosure are directed tonon-transitory, computer-readable medium having stored thereon logicthat, when executed by one or more processors, causes operationsincluding providing an incident light signal to the optical fiber, wherethe optical fiber is coupled to a deployable medical device, receiving areflected light signal of the incident light, and processing thereflected light signal to determine deployment information pertaining todeployment of the deployable medical device.

In some embodiments, each of the one or more core fibers includes aplurality of sensors distributed along a longitudinal length of acorresponding core fiber and each sensor of the plurality of sensors isconfigured to (i) reflect a light signal of a different spectral widthbased on received incident light, and (ii) change a characteristic ofthe reflected light signal for use in determining a physical state ofthe optical fiber. In some embodiments, the deployment informationincludes at least one of a location of the deployment, a status of thedeployment, measurements of the deployable medical device in a deployedstate or a shape of the deployed medical device.

In other embodiments, the optical fiber is a multi-core optical fiberincluding a plurality of core fibers, and wherein the incident lightpropagates along a first core fiber and the reflect light signalpropagates along a second core fiber. In yet some embodiments, thelogic, when executed by the one or more processors, causes furtheroperations including generating a visualization of representing thedeployable medical device within the patient body in a non-deployedstate and in a deployed state. In still some embodiments, the logic,when executed by the one or more processors, causes further operationsincluding generating a display indicating the location of the distal tipof the optical fiber within the patient body.

In some embodiments, the medical instrument is one of an introducerwire, a guidewire, a stylet, a stylet within a needle, a needle with theoptical fiber inlayed into a cannula of the needle or a catheter withthe optical fiber inlayed into one or more walls of the catheter. Insome embodiments, the medical device is one of a balloon, a filter, astent or a valve. In some particular embodiments when the medical deviceis a stent, the logic, when executed by the one or more processors,causes further operations including determining a diameter of the stentin a deployed state. In some embodiments, the optical fiber is disposedwithin a groove, channel or lumen of the medical device duringadvancement of the medical device within the patient body.

These and other features of the concepts provided herein will becomemore apparent to those of skill in the art in view of the accompanyingdrawings and following description, which disclose particularembodiments of such concepts in greater detail.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the disclosure are illustrated by way of example and notby way of limitation in the figures of the accompanying drawings, inwhich like references indicate similar elements and in which:

FIG. 1A is an illustrative embodiment of a medical instrument monitoringsystem including a medical instrument with optic shape sensing and fiberoptic-based oximetry capabilities in accordance with some embodiments;

FIG. 1B is an alternative illustrative embodiment of the medicalinstrument monitoring system 100 in accordance with some embodiments;

FIG. 2 is an exemplary embodiment of a structure of a section of themulti-core optical fiber included within the stylet 120 of FIG. 1A inaccordance with some embodiments;

FIG. 3A is a first exemplary embodiment of the stylet of FIG. 1Asupporting both an optical and electrical signaling in accordance withsome embodiments;

FIG. 3B is a cross sectional view of the stylet of FIG. 3A in accordancewith some embodiments;

FIG. 4A is a second exemplary embodiment of the stylet of FIG. 1B inaccordance with some embodiments;

FIG. 4B is a cross sectional view of the stylet of FIG. 4A in accordancewith some embodiments;

FIG. 5A is an elevation view of a first illustrative embodiment of acatheter including integrated tubing, a diametrically disposed septum,and micro-lumens formed within the tubing and septum in accordance withsome embodiments;

FIG. 5B is a perspective view of the first illustrative embodiment ofthe catheter of FIG. 5A including core fibers installed within themicro-lumens in accordance with some embodiments;

FIGS. 6A-6B are flowcharts of the methods of operations conducted by themedical instrument monitoring system of FIGS. 1A-1B to achieve optic 3Dshape sensing in accordance with some embodiments;

FIG. 7 is an exemplary embodiment of the medical instrument monitoringsystem of FIG. 1A during operation and insertion of the catheter into apatient in accordance with some embodiments;

FIGS. 8A-8C are cross-sectional views of a medical instrument disposedwithin a vessel where a balloon extends from a distal end of the medicalinstrument configured to deploy a stent within the vessel in accordancewith some embodiments;

FIG. 8D is a detailed illustration of a portion of a stent surrounding aballoon where the stent includes a channel or groove configured to housean optical fiber in accordance with some embodiments;

FIG. 9A is a perspective view of a medical instrument having a balloonextending from a distal end where an optical fiber extends along alength of the medical instrument and is detachably coupled to theballoon in a first configuration in accordance with some embodiments;

FIG. 9B is a perspective view of the medical instrument of FIG. 9A wherethe optical fiber extends along a length of the medical instrument andis detachably coupled to the balloon in a second configuration inaccordance with some embodiments;

FIG. 10A is a perspective view of a medical instrument having a balloonextending from a distal end where an optical fiber extends along thelength of the medical instrument and is detachably coupled to animplantable valve disposed around the balloon in accordance with someembodiments;

FIG. 10B is a cross-sectional view of the medical instrument, theballoon and the implantable valve of FIG. 10A disposed within a patientbody in accordance with some embodiments;

FIG. 10C is an illustration of an implantable valve that includes agroove, channel or lumen configured to enclose or encapsulate an opticalfiber in accordance with some embodiments;

FIG. 11A is a perspective view of an implantable valve detachablycoupled with a plurality of optical fibers in accordance with someembodiments;

FIG. 11B is a cross-sectional view of the implantable valve of FIG. 11Adisposed within a vessel in accordance with some embodiments;

FIG. 12A is a perspective view of a medical instrument deploying a coilwhere an optical fiber is detachably coupled to the coil in accordancewith some embodiments;

FIG. 12B is a cross-sectional view of the medical instrument of FIG. 12Adeploying a coil within an aneurysm where an optical fiber is detachablycoupled to the coil in accordance with some embodiments;

FIG. 12C is an illustration of a portion of a coil in a deployed stateincluding a groove in which an optical fiber rests in accordance withsome embodiments;

FIG. 12D is an illustration of a coil that includes a lumen configuredto enclose or encapsulate an optical fiber in accordance with someembodiments;

FIG. 13 is a perspective view of a deployable filter detachably coupledto an optical fiber in accordance with some embodiments; and

FIG. 14 is an exemplary embodiment of the console of FIG. 1B coupled toa medical instrument and a medical device during operation to deploy themedical device into a patient in accordance with some embodiments.

DETAILED DESCRIPTION

Before some particular embodiments are disclosed in greater detail, itshould be understood that the particular embodiments disclosed herein donot limit the scope of the concepts provided herein. It should also beunderstood that a particular embodiment disclosed herein can havefeatures that can be readily separated from the particular embodimentand optionally combined with or substituted for features of any of anumber of other embodiments disclosed herein.

Regarding terms used herein, it should also be understood the terms arefor the purpose of describing some particular embodiments, and the termsdo not limit the scope of the concepts provided herein. Ordinal numbers(e.g., first, second, third, etc.) are generally used to distinguish oridentify different features or steps in a group of features or steps,and do not supply a serial or numerical limitation. For example,“first,” “second,” and “third” features or steps need not necessarilyappear in that order, and the particular embodiments including suchfeatures or steps need not necessarily be limited to the three featuresor steps. Labels such as “left,” “right,” “top,” “bottom,” “front,”“back,” and the like are used for convenience and are not intended toimply, for example, any particular fixed location, orientation, ordirection. Instead, such labels are used to reflect, for example,relative location, orientation, or directions. Singular forms of “a,”“an,” and “the” include plural references unless the context clearlydictates otherwise.

With respect to “proximal,” a “proximal portion” or a “proximal endportion” of, for example, a probe disclosed herein includes a portion ofthe probe intended to be near a clinician when the probe is used on apatient. Likewise, a “proximal length” of, for example, the probeincludes a length of the probe intended to be near the clinician whenthe probe is used on the patient. A “proximal end” of, for example, theprobe includes an end of the probe intended to be near the clinicianwhen the probe is used on the patient. The proximal portion, theproximal end portion, or the proximal length of the probe can includethe proximal end of the probe; however, the proximal portion, theproximal end portion, or the proximal length of the probe need notinclude the proximal end of the probe. That is, unless context suggestsotherwise, the proximal portion, the proximal end portion, or theproximal length of the probe is not a terminal portion or terminallength of the probe.

With respect to “distal,” a “distal portion” or a “distal end portion”of, for example, a probe disclosed herein includes a portion of theprobe intended to be near or in a patient when the probe is used on thepatient. Likewise, a “distal length” of, for example, the probe includesa length of the probe intended to be near or in the patient when theprobe is used on the patient. A “distal end” of, for example, the probeincludes an end of the probe intended to be near or in the patient whenthe probe is used on the patient. The distal portion, the distal endportion, or the distal length of the probe can include the distal end ofthe probe; however, the distal portion, the distal end portion, or thedistal length of the probe need not include the distal end of the probe.That is, unless context suggests otherwise, the distal portion, thedistal end portion, or the distal length of the probe is not a terminalportion or terminal length of the probe.

The term “logic” may be representative of hardware, firmware or softwarethat is configured to perform one or more functions. As hardware, theterm logic may refer to or include circuitry having data processingand/or storage functionality. Examples of such circuitry may include,but are not limited or restricted to a hardware processor (e.g.,microprocessor, one or more processor cores, a digital signal processor,a programmable gate array, a microcontroller, an application specificintegrated circuit “ASIC”, etc.), a semiconductor memory, orcombinatorial elements.

Additionally, or in the alternative, the term logic may refer to orinclude software such as one or more processes, one or more instances,Application Programming Interface(s) (API), subroutine(s), function(s),applet(s), servlet(s), routine(s), source code, object code, sharedlibrary/dynamic link library (dll), or even one or more instructions.This software may be stored in any type of a suitable non-transitorystorage medium, or transitory storage medium (e.g., electrical, optical,acoustical or other form of propagated signals such as carrier waves,infrared signals, or digital signals). Examples of a non-transitorystorage medium may include, but are not limited or restricted to aprogrammable circuit; non-persistent storage such as volatile memory(e.g., any type of random-access memory “RAM”); or persistent storagesuch as non-volatile memory (e.g., read-only memory “ROM”, power-backedRAM, flash memory, phase-change memory, etc.), a solid-state drive, harddisk drive, an optical disc drive, or a portable memory device. Asfirmware, the logic may be stored in persistent storage.

Referring to FIG. 1A, an illustrative embodiment of a medical instrumentmonitoring system including a medical instrument with optic shapesensing and fiber optic-based oximetry capabilities is shown inaccordance with some embodiments. As shown, the system 100 generallyincludes a console 110 and a stylet assembly 119 communicatively coupledto the console 110. For this embodiment, the stylet assembly 119includes an elongate probe (e.g., stylet) 120 on its distal end 122 anda console connector 133 on its proximal end 124, where the stylet 120 isconfigured to advance within a patient vasculature either through, or inconjunction with, a catheter 195. The console connector 133 enables thestylet assembly 119 to be operably connected to the console 110 via aninterconnect 145 including one or more optical fibers 147 (hereinafter,“optical fiber(s)”) and a conductive medium terminated by a singleoptical/electric connector 146 (or terminated by dual connectors).Herein, the connector 146 is configured to engage (mate) with theconsole connector 133 to allow for the propagation of light between theconsole 110 and the stylet assembly 119 as well as the propagation ofelectrical signals from the stylet 120 to the console 110.

An exemplary implementation of the console 110 includes a processor 160,a memory 165, a display 170 and optical logic 180, although it isappreciated that the console 110 can take one of a variety of forms andmay include additional components (e.g., power supplies, ports,interfaces, etc.) that are not directed to aspects of the disclosure. Anillustrative example of the console 110 is illustrated in U.S. Pat. No.10,992,078, the entire contents of which are incorporated by referenceherein. The processor 160, with access to the memory 165 (e.g.,non-volatile memory or non-transitory, computer-readable medium), isincluded to control functionality of the console 110 during operation.As shown, the display 170 may be a liquid crystal diode (LCD) displayintegrated into the console 110 and employed as a user interface todisplay information to the clinician, especially during a catheterplacement procedure (e.g., cardiac catheterization). In anotherembodiment, the display 170 may be separate from the console 110.Although not shown, a user interface is configured to provide usercontrol of the console 110.

For both embodiments, the content depicted by the display 170 may changeaccording to which mode the stylet 120 is configured to operate:optical, TLS, ECG, or another modality. In TLS mode, the contentrendered by the display 170 may constitute a two-dimensional (2D) orthree-dimensional (3D) representation of the physical state (e.g.,length, shape, form, and/or orientation) of the stylet 120 computed fromcharacteristics of reflected light signals 150 returned to the console110. The reflected light signals 150 constitute light of a specificspectral width of broadband incident light 155 reflected back to theconsole 110. According to one embodiment of the disclosure, thereflected light signals 150 may pertain to various discrete portions(e.g., specific spectral widths) of broadband incident light 155transmitted from and sourced by the optical logic 180, as describedbelow

According to one embodiment of the disclosure, an activation control126, included on the stylet assembly 119, may be used to set the stylet120 into a desired operating mode and selectively alter operability ofthe display 170 by the clinician to assist in medical device placement.For example, based on the modality of the stylet 120, the display 170 ofthe console 110 can be employed for optical modality-based guidanceduring catheter advancement through the vasculature or TLS modality todetermine the physical state (e.g., length, form, shape, orientation,etc.) of the stylet 120. In one embodiment, information from multiplemodes, such as optical, TLS or ECG for example, may be displayedconcurrently (e.g., at least partially overlapping in time).

Referring still to FIG. 1A, the optical logic 180 is configured tosupport operability of the stylet assembly 119 and enable the return ofinformation to the console 110, which may be used to determine thephysical state associated with the stylet 120 along with monitoredelectrical signals such as ECG signaling via an electrical signalinglogic 181 that supports receipt and processing of the receivedelectrical signals from the stylet 120 (e.g., ports, analog-to-digitalconversion logic, etc.). The physical state of the stylet 120 may bebased on changes in characteristics of the reflected light signals 150received at the console 110 from the stylet 120. The characteristics mayinclude shifts in wavelength caused by strain on certain regions of thecore fibers integrated within an optical fiber core 135 positionedwithin or operating as the stylet 120, as shown below. As discussedherein, the optical fiber core 135 may be comprised of core fibers 137₁-137 _(M) (M=1 for a single core, and M≥2 for a multi-core), where thecore fibers 137 ₁-137 _(M) may collectively be referred to as corefiber(s) 137. Unless otherwise specified or the instant embodimentrequires an alternative interpretation, embodiments discussed hereinwill refer to a multi-core optical fiber 135. From informationassociated with the reflected light signals 150, the console 110 maydetermine (through computation or extrapolation of the wavelengthshifts) the physical state of the stylet 120, and that of the catheter195 configured to receive the stylet 120.

According to one embodiment of the disclosure, as shown in FIG. 1A, theoptical logic 180 may include a light source 182 and an optical receiver184. The light source 182 is configured to transmit the incident light155 (e.g., broadband) for propagation over the optical fiber(s) 147included in the interconnect 145, which are optically connected to themulti-core optical fiber core 135 within the stylet 120. In oneembodiment, the light source 182 is a tunable swept laser, althoughother suitable light sources can also be employed in addition to alaser, including semi-coherent light sources, LED light sources, etc.

The optical receiver 184 is configured to: (i) receive returned opticalsignals, namely reflected light signals 150 received from opticalfiber-based reflective gratings (sensors) fabricated within each corefiber of the multi-core optical fiber 135 deployed within the stylet120, and (ii) translate the reflected light signals 150 into reflectiondata (from repository 192), namely data in the form of electricalsignals representative of the reflected light signals includingwavelength shifts caused by strain. The reflected light signals 150associated with different spectral widths may include reflected lightsignals 151 provided from sensors positioned in the center core fiber(reference) of the multi-core optical fiber 135 and reflected lightsignals 152 provided from sensors positioned in the periphery corefibers of the multi-core optical fiber 135, as described below. Herein,the optical receiver 184 may be implemented as a photodetector, such asa positive-intrinsic-negative “PIN” photodiode, avalanche photodiode, orthe like.

As shown, both the light source 182 and the optical receiver 184 areoperably connected to the processor 160, which governs their operation.Also, the optical receiver 184 is operably coupled to provide thereflection data (from repository 192) to the memory 165 for storage andprocessing by reflection data classification logic 190. The reflectiondata classification logic 190 may be configured to: (i) identify whichcore fibers pertain to which of the received reflection data (fromrepository 192) and (ii) segregate the reflection data stored with arepository 192 provided from reflected light signals 150 pertaining tosimilar regions of the stylet 120 or spectral widths into analysisgroups. The reflection data for each analysis group is made available toshape sensing logic 194 for analytics.

According to one embodiment of the disclosure, the shape sensing logic194 is configured to compare wavelength shifts measured by sensorsdeployed in each periphery core fiber at the same measurement region ofthe stylet 120 (or same spectral width) to the wavelength shift at acenter core fiber of the multi-core optical fiber 135 positioned alongcentral axis and operating as a neutral axis of bending. From theseanalytics, the shape sensing logic 194 may determine the shape the corefibers have taken in 3D space and may further determine the currentphysical state of the catheter 195 in 3D space for rendering on thedisplay 170.

According to one embodiment of the disclosure, the shape sensing logic194 may generate a rendering of the current physical state of the stylet120 (and potentially the catheter 195), based on heuristics or run-timeanalytics. For example, the shape sensing logic 194 may be configured inaccordance with machine-learning techniques to access a data store(library) with pre-stored data (e.g., images, etc.) pertaining todifferent regions of the stylet 120 (or catheter 195) in which reflectedlight from core fibers have previously experienced similar or identicalwavelength shifts. From the pre-stored data, the current physical stateof the stylet 120 (or catheter 195) may be rendered. Alternatively, asanother example, the shape sensing logic 194 may be configured todetermine, during run-time, changes in the physical state of each regionof the multi-core optical fiber 135 based on at least: (i) resultantwavelength shifts experienced by different core fibers within theoptical fiber 135, and (ii) the relationship of these wavelength shiftsgenerated by sensors positioned along different periphery core fibers atthe same cross-sectional region of the multi-core optical fiber 135 tothe wavelength shift generated by a sensor of the center core fiber atthe same cross-sectional region. It is contemplated that other processesand procedures may be performed to utilize the wavelength shifts asmeasured by sensors along each of the core fibers within the multi-coreoptical fiber 135 to render appropriate changes in the physical state ofthe stylet 120 (and/or catheter 195), especially to enable guidance ofthe stylet 120, when positioned at a distal tip of the catheter 195,within the vasculature of the patient and at a desired destinationwithin the body.

The console 110 may further include electrical signaling logic 181,which is positioned to receive one or more electrical signals from thestylet 120. The stylet 120 is configured to support both opticalconnectivity as well as electrical connectivity. The electricalsignaling logic 181 receives the electrical signals (e.g., ECG signals)from the stylet 120 via the conductive medium. The electrical signalsmay be processed by electrical signal logic 196, executed by theprocessor 160, to determine ECG waveforms for display.

Referring to FIG. 1B, an alternative exemplary embodiment of a medicalinstrument monitoring system 100 is shown. Herein, the medicalinstrument monitoring system 100 features a console 110 and a medicalinstrument 130 communicatively coupled to the console 110. For thisembodiment, the medical instrument 130 corresponds to a catheter, whichfeatures an integrated tubing with two or more lumen extending between aproximal end 131 and a distal end 132 of the integrated tubing. Theintegrated tubing (sometimes referred to as “catheter tubing”) is incommunication with one or more extension legs 140 via a bifurcation hub142. An optical-based catheter connector 144 may be included on aproximal end of at least one of the extension legs 140 to enable thecatheter 130 to operably connect to the console 110 via an interconnect145 or another suitable component. Herein, the interconnect 145 mayinclude a connector 146 that, when coupled to the optical-based catheterconnector 144, establishes optical connectivity between one or moreoptical fibers 147 (hereinafter, “optical fiber(s)”) included as part ofthe interconnect 145 and core fibers 137 deployed within the catheter130 and integrated into the tubing. Alternatively, a differentcombination of connectors, including one or more adapters, may be usedto optically connect the optical fiber(s) 147 to the core fibers 137within the catheter 130. The core fibers 137 deployed within thecatheter 130 as illustrated in FIG. 1B include the same characteristicsand perform the same functionalities as the core fibers 137 deployedwithin the stylet 120 of FIG. 1A.

The optical logic 180 is configured to support graphical rendering ofthe catheter 130, most notably the integrated tubing of the catheter130, based on characteristics of the reflected light signals 150received from the catheter 130. The characteristics may include shiftsin wavelength caused by strain on certain regions of the core fibers 137integrated within (or along) a wall of the integrated tubing, which maybe used to determine (through computation or extrapolation of thewavelength shifts) the physical state of the catheter 130, notably itsintegrated tubing or a portion of the integrated tubing such as a tip ordistal end of the tubing to read fluctuations (real-time movement) ofthe tip (or distal end).

More specifically, the optical logic 180 includes a light source 182.The light source 182 is configured to transmit the broadband incidentlight 155 for propagation over the optical fiber(s) 147 included in theinterconnect 145, which are optically connected to multiple core fibers137 within the catheter tubing. Herein, the optical receiver 184 isconfigured to: (i) receive returned optical signals, namely reflectedlight signals 150 received from optical fiber-based reflective gratings(sensors) fabricated within each of the core fibers 137 deployed withinthe catheter 130, and (ii) translate the reflected light signals 150into reflection data (from repository 192), namely data in the form ofelectrical signals representative of the reflected light signalsincluding wavelength shifts caused by strain. The reflected lightsignals 150 associated with different spectral widths include reflectedlight signals 151 provided from sensors positioned in the center corefiber (reference) of the catheter 130 and reflected light signals 152provided from sensors positioned in the outer core fibers of thecatheter 130, as described below.

As noted above, the shape sensing logic 194 is configured to comparewavelength shifts measured by sensors deployed in each outer core fiberat the same measurement region of the catheter (or same spectral width)to the wavelength shift at the center core fiber positioned alongcentral axis and operating as a neutral axis of bending. From theseanalytics, the shape sensing logic 190 may determine the shape the corefibers have taken in 3D space and may further determine the currentphysical state of the catheter 130 in 3D space for rendering on thedisplay 170.

According to one embodiment of the disclosure, the shape sensing logic194 may generate a rendering of the current physical state of thecatheter 130, especially the integrated tubing, based on heuristics orrun-time analytics. For example, the shape sensing logic 194 may beconfigured in accordance with machine-learning techniques to access adata store (library) with pre-stored data (e.g., images, etc.)pertaining to different regions of the catheter 130 in which the corefibers 137 experienced similar or identical wavelength shifts. From thepre-stored data, the current physical state of the catheter 130 may berendered. Alternatively, as another example, the shape sensing logic 194may be configured to determine, during run-time, changes in the physicalstate of each region of the catheter 130, notably the tubing, based onat least (i) resultant wavelength shifts experienced by the core fibers137 and (ii) the relationship of these wavelength shifts generated bysensors positioned along different outer core fibers at the samecross-sectional region of the catheter 130 to the wavelength shiftgenerated by a sensor of the center core fiber at the samecross-sectional region. It is contemplated that other processes andprocedures may be performed to utilize the wavelength shifts as measuredby sensors along each of the core fibers 137 to render appropriatechanges in the physical state of the catheter 130.

Referring to FIG. 2, an exemplary embodiment of a structure of a sectionof the multi-core optical fiber included within the stylet 120 of FIG.1A is shown in accordance with some embodiments. The multi-core opticalfiber section 200 of the multi-core optical fiber 135 depicts certaincore fibers 137 ₁-137 _(M) (M≥2, M=4 as shown, see FIG. 3A) along withthe spatial relationship between sensors (e.g., reflective gratings) 210₁₁-210 _(NM) (N≥2; M≥2) present within the core fibers 137 ₁-137 _(M),respectively. As noted above, the core fibers 137 ₁-137 _(M) may becollectively referred to as “the core fibers 137.”

As shown, the section 200 is subdivided into a plurality ofcross-sectional regions 220 ₁-220 _(N), where each cross-sectionalregion 220 ₁-220 _(N) corresponds to reflective gratings 210 ₁₁-210 ₁₄ .. . 210 _(N1)-210 _(N4). Some or all of the cross-sectional regions 220₁ . . . 220 _(N) may be static (e.g., prescribed length) or may bedynamic (e.g., vary in size among the regions 220 ₁ . . . 220 _(N)). Afirst core fiber 137 ₁ is positioned substantially along a center(neutral) axis 230 while core fiber 137 ₂ may be oriented within thecladding of the multi-core optical fiber 135, from a cross-sectional,front-facing perspective, to be position on “top” the first core fiber137 ₁. In this deployment, the core fibers 137 ₃ and 137 ₄ may bepositioned “bottom left” and “bottom right” of the first core fiber 137₁. As examples, FIGS. 3A-4B provides illustrations of such.

Referencing the first core fiber 137 ₁ as an illustrative example, whenthe stylet 120 is operative, each of the reflective gratings 210 ₁-210_(N) reflects light for a different spectral width. As shown, each ofthe gratings 210 ₁₁-210 _(Ni) (1≤i≤M) is associated with a different,specific spectral width, which would be represented by different centerfrequencies of f₁ . . . f_(N), where neighboring spectral widthsreflected by neighboring gratings are non-overlapping according to oneembodiment of the disclosure.

Herein, positioned in different core fibers 137 ₂-137 ₃ but along at thesame cross-sectional regions 220-220 _(N) of the multi-core opticalfiber 135, the gratings 210 ₁₂-210 _(N2) and 210 ₁₃-210 _(N3) areconfigured to reflect incoming light at same (or substantially similar)center frequency. As a result, the reflected light returns informationthat allows for a determination of the physical state of the opticalfibers 137 (and the stylet 120) based on wavelength shifts measured fromthe returned, reflected light. In particular, strain (e.g., compressionor tension) applied to the multi-core optical fiber 135 (e.g., at leastcore fibers 137 ₂-137 ₃) results in wavelength shifts associated withthe returned, reflected light. Based on different locations, the corefibers 137 ₁-137 ₄ experience different types and degree of strain basedon angular path changes as the stylet 120 advances in the patient.

For example, with respect to the multi-core optical fiber section 200 ofFIG. 2, in response to angular (e.g., radial) movement of the stylet 120is in the left-veering direction, the fourth core fiber 137 ₄ (see FIG.3A) of the multi-core optical fiber 135 with the shortest radius duringmovement (e.g., core fiber closest to a direction of angular change)would exhibit compression (e.g., forces to shorten length). At the sametime, the third core fiber 137 ₃ with the longest radius during movement(e.g., core fiber furthest from the direction of angular change) wouldexhibit tension (e.g., forces to increase length). As these forces aredifferent and unequal, the reflected light from reflective gratings 210_(N2) and 210 _(N3) associated with the core fibers 137 ₂ and 137 ₃ willexhibit different changes in wavelength. The differences in wavelengthshift of the reflected light signals 150 can be used to extrapolate thephysical configuration of the stylet 120 by determining the degrees ofwavelength change caused by compression/tension for each of theperiphery fibers (e.g., the second core fiber 137 ₂ and the third corefiber 137 ₃) in comparison to the wavelength of the reference core fiber(e.g., first core fiber 137 ₁) located along the neutral axis 230 of themulti-core optical fiber 135. These degrees of wavelength change may beused to extrapolate the physical state of the stylet 120. The reflectedlight signals 150 are reflected back to the console 110 via individualpaths over a particular core fiber 137 ₁-137 _(M).

Referring to FIG. 3A, a first exemplary embodiment of the stylet of FIG.1A supporting both an optical and electrical signaling is shown inaccordance with some embodiments. Herein, the stylet 120 features acentrally located multi-core optical fiber 135, which includes acladding 300 and a plurality of core fibers 137 ₁-137 _(M) (M≥2; M=4)residing within a corresponding plurality of lumens 320 ₁-320 _(M).While the multi-core optical fiber 135 is illustrated within four (4)core fibers 137 ₁-137 ₄, a greater number of core fibers 137 ₁-137 _(M)(M>4) may be deployed to provide a more detailed three-dimensionalsensing of the physical state (e.g., shape, etc.) of the multi-coreoptical fiber 135 and the stylet 120 deploying the optical fiber 135.

For this embodiment of the disclosure, the multi-core optical fiber 135is encapsulated within a concentric braided tubing 310 positioned over alow coefficient of friction layer 335. The braided tubing 310 mayfeature a “mesh” construction, in which the spacing between theintersecting conductive elements is selected based on the degree ofrigidity desired for the stylet 120, as a greater spacing may provide alesser rigidity, and thereby, a more pliable stylet 120.

According to this embodiment of the disclosure, as shown in FIGS. 3A-3B,the core fibers 137 ₁-137 ₄ include (i) a central core fiber 137 ₁ and(ii) a plurality of periphery core fibers 137 ₂-137 ₄, which aremaintained within lumens 320 ₁-320 ₄ formed in the cladding 300.According to one embodiment of the disclosure, one or more of the lumens320 ₁-320 ₄ may be configured with a diameter sized to be greater thanthe diameter of the core fibers 137 ₁-137 ₄. By avoiding a majority ofthe surface area of the core fibers 137 ₁-137 ₄ from being in directphysical contact with a wall surface of the lumens 320 ₁-320 ₄, thewavelength changes to the incident light are caused by angulardeviations in the multi-core optical fiber 135 thereby reducinginfluence of compression and tension forces being applied to the wallsof the lumens 320 ₁-320 _(M), not the core fibers 137 ₁-137 _(M)themselves.

As further shown in FIGS. 3A-3B, the core fibers 137 ₁-137 ₄ may includecentral core fiber 137 ₁ residing within a first lumen 320 ₁ formedalong the first neutral axis 230 and a plurality of core fibers 137₂-137 ₄ residing within lumens 320 ₂-320 ₄ each formed within differentareas of the cladding 300 radiating from the first neutral axis 230. Ingeneral, the core fibers 137 ₂-137 ₄, exclusive of the central corefiber 137 ₁, may be positioned at different areas within across-sectional area 305 of the cladding 300 to provide sufficientseparation to enable three-dimensional sensing of the multi-core opticalfiber 135 based on changes in wavelength of incident light propagatingthrough the core fibers 137 ₂-137 ₄ and reflected back to the consolefor analysis.

For example, where the cladding 300 features a circular cross-sectionalarea 305 as shown in FIG. 3B, the core fibers 137 ₂-137 ₄ may bepositioned substantially equidistant from each other as measured along aperimeter of the cladding 300, such as at “top” (12 o'clock),“bottom-left” (8 o'clock) and “bottom-right” (4 o'clock) locations asshown. Hence, in general terms, the core fibers 137 ₂-137 ₄ may bepositioned within different segments of the cross-sectional area 305.Where the cross-sectional area 305 of the cladding 300 has a distal tip330 and features a polygon cross-sectional shape (e.g., triangular,square, rectangular, pentagon, hexagon, octagon, etc.), the central corefiber 137 ₁ may be located at or near a center of the polygon shape,while the remaining core fibers 137 ₂-137 _(M) may be located proximateto angles between intersecting sides of the polygon shape.

Referring still to FIGS. 3A-3B, operating as the conductive medium forthe stylet 120, the braided tubing 310 provides mechanical integrity tothe multi-core optical fiber 135 and operates as a conductive pathwayfor electrical signals. For example, the braided tubing 310 may beexposed to a distal tip of the stylet 120. The cladding 300 and thebraided tubing 310, which is positioned concentrically surrounding acircumference of the cladding 300, are contained within the sameinsulating layer 350. The insulating layer 350 may be a sheath orconduit made of protective, insulating (e.g., non-conductive) materialthat encapsulates both for the cladding 300 and the braided tubing 310,as shown.

Referring to FIG. 4A, a second exemplary embodiment of the stylet ofFIG. 1A is shown in accordance with some embodiments. Herein, the stylet120 features the multi-core optical fiber 135 described above and shownin FIG. 3A, which includes the cladding 300 and the first plurality ofcore fibers 137 ₁-137 _(M) (M≥3; M=4 for embodiment) residing within thecorresponding plurality of lumens 320 ₁-320 _(M). For this embodiment ofthe disclosure, the multi-core optical fiber 135 includes the centralcore fiber 137 ₁ residing within the first lumen 320 ₁ formed along thefirst neutral axis 230 and the second plurality of core fibers 137 ₂-137₄ residing within corresponding lumens 320 ₂-320 ₄ positioned indifferent segments within the cross-sectional area 305 of the cladding300. Herein, the multi-core optical fiber 135 is encapsulated within aconductive tubing 400. The conductive tubing 400 may feature a “hollow”conductive cylindrical member concentrically encapsulating themulti-core optical fiber 135.

Referring to FIGS. 4A-4B, operating as a conductive medium for thestylet 120 in the transfer of electrical signals (e.g., ECG signals) tothe console, the conductive tubing 400 may be exposed up to a tip 410 ofthe stylet 120. For this embodiment of the disclosure, a conductiveepoxy 420 (e.g., metal-based epoxy such as a silver epoxy) may beaffixed to the tip 410 and similarly joined with atermination/connection point created at a proximal end 430 of the stylet120. The cladding 300 and the conductive tubing 400, which is positionedconcentrically surrounding a circumference of the cladding 300, arecontained within the same insulating layer 440. The insulating layer 440may be a protective conduit encapsulating both for the cladding 300 andthe conductive tubing 400, as shown.

Referring to FIG. 5A, an elevation view of a first illustrativeembodiment of a catheter including integrated tubing, a diametricallydisposed septum, and micro-lumens formed within the tubing and septum isshown in accordance with some embodiments. Herein, the catheter 130includes integrated tubing, the diametrically disposed septum 510, andthe plurality of micro-lumens 530 ₁-530 ₄ which, for this embodiment,are fabricated to reside within the wall 500 of the integrated tubing ofthe catheter 130 and within the septum 510. In particular, the septum510 separates a single lumen, formed by the inner surface 505 of thewall 500 of the catheter 130, into multiple lumens, namely two lumens540 and 545 as shown. Herein, the first lumen 540 is formed between afirst arc-shaped portion 535 of the inner surface 505 of the wall 500forming the catheter 130 and a first outer surface 555 of the septum 510extending longitudinally within the catheter 130. The second lumen 545is formed between a second arc-shaped portion 565 of the inner surface505 of the wall 500 forming the catheter 130 and a second outer surfaces560 of the septum 510.

According to one embodiment of the disclosure, the two lumens 540 and545 have approximately the same volume. However, the septum 510 need notseparate the tubing into two equal lumens. For example, instead of theseptum 510 extending vertically (12 o'clock to 6 o'clock) from afront-facing, cross-sectional perspective of the tubing, the septum 510could extend horizontally (3 o'clock to 9 o'clock), diagonally (1o'clock to 7 o'clock; 10 o'clock to 4 o'clock) or angularly (2 o'clockto 10 o'clock). In the later configuration, each of the lumens 540 and545 of the catheter 130 would have a different volume.

With respect to the plurality of micro-lumens 530 ₁-530 ₄, the firstmicro-lumen 530 ₁ is fabricated within the septum 510 at or near thecross-sectional center 525 of the integrated tubing. For thisembodiment, three micro-lumens 530 ₂-530 ₄ are fabricated to residewithin the wall 500 of the catheter 130. In particular, a secondmicro-lumen 530 ₂ is fabricated within the wall 500 of the catheter 130,namely between the inner surface 505 and outer surface 507 of the firstarc-shaped portion 535 of the wall 500. Similarly, the third micro-lumen530 ₃ is also fabricated within the wall 500 of the catheter 130, namelybetween the inner and outer surfaces 505/507 of the second arc-shapedportion 555 of the wall 500. The fourth micro-lumen 530 ₄ is alsofabricated within the inner and outer surfaces 505/507 of the wall 500that are aligned with the septum 510.

According to one embodiment of the disclosure, as shown in FIG. 5A, themicro-lumens 530 ₂-530 ₄ are positioned in accordance with a “top-left”(10 o'clock), “top-right” (2 o'clock) and “bottom” (6 o'clock) layoutfrom a front-facing, cross-sectional perspective. Of course, themicro-lumens 530 ₂-530 ₄ may be positioned differently, provided thatthe micro-lumens 530 ₂-530 ₄ are spatially separated along thecircumference 520 of the catheter 130 to ensure a more robust collectionof reflected light signals from the outer core fibers 570 ₂-570 ₄ wheninstalled. For example, two or more of micro-lumens (e.g., micro-lumens530 ₂ and 530 ₄) may be positioned at different quadrants along thecircumference 520 of the catheter wall 500.

Referring to FIG. 5B, a perspective view of the first illustrativeembodiment of the catheter of FIG. 5A including core fibers installedwithin the micro-lumens is shown in accordance with some embodiments.According to one embodiment of the disclosure, the second plurality ofmicro-lumens 530 ₂-530 ₄ are sized to retain corresponding outer corefibers 570 ₂-570 ₄, where the diameter of each of the second pluralityof micro-lumens 530 ₂-530 ₄ may be sized just larger than the diametersof the outer core fibers 570 ₂-570 ₄. The size differences between adiameter of a single core fiber and a diameter of any of the micro-lumen530 ₁-530 ₄ may range between 0.001 micrometers (μm) and 1000 μm, forexample. As a result, the cross-sectional areas of the outer core fibers570 ₂-570 ₄ would be less than the cross-sectional areas of thecorresponding micro-lumens 530 ₂-530 ₄. A “larger” micro-lumen (e.g.,micro-lumen 530 ₂) may better isolate external strain being applied tothe outer core fiber 570 ₂ from strain directly applied to the catheter130 itself. Similarly, the first micro-lumen 530 ₁ may be sized toretain the center core fiber 570 ₁, where the diameter of the firstmicro-lumen 530 ₁ may be sized just larger than the diameter of thecenter core fiber 570 ₁.

As an alternative embodiment of the disclosure, one or more of themicro-lumens 530 ₁-530 ₄ may be sized with a diameter that exceeds thediameter of the corresponding one or more core fibers 570 ₁-570 ₄.However, at least one of the micro-lumens 530 ₁-530 ₄ is sized tofixedly retain their corresponding core fiber (e.g., core fiber retainedwith no spacing between its lateral surface and the interior wallsurface of its corresponding micro-lumen). As yet another alternativeembodiment of the disclosure, all the micro-lumens 530 ₁-530 ₄ are sizedwith a diameter to fixedly retain the core fibers 570 ₁-570 ₄.

Referring to FIGS. 6A-6B, flowcharts of methods of operations conductedby the medical instrument monitoring system of FIGS. 1A-1B to achieveoptic 3D shape sensing are shown in accordance with some embodiments.Herein, the catheter includes at least one septum spanning across adiameter of the tubing wall and continuing longitudinally to subdividethe tubing wall. The medial portion of the septum is fabricated with afirst micro-lumen, where the first micro-lumen is coaxial with thecentral axis of the catheter tubing. The first micro-lumen is configuredto retain a center core fiber. Two or more micro-lumen, other than thefirst micro-lumen, are positioned at different locationscircumferentially spaced along the wall of the catheter tubing. Forexample, two or more of the second plurality of micro-lumens may bepositioned at different quadrants along the circumference of thecatheter wall.

Furthermore, each core fiber includes a plurality of sensors spatiallydistributed along its length between at least the proximal and distalends of the catheter tubing. This array of sensors is distributed toposition sensors at different regions of the core fiber to enabledistributed measurements of strain throughout the entire length or aselected portion of the catheter tubing. These distributed measurementsmay be conveyed through reflected light of different spectral widths(e.g., specific wavelength or specific wavelength ranges) that undergoescertain wavelength shifts based on the type and degree of strain.

According to one embodiment of the disclosure, as shown in FIG. 6A, foreach core fiber, broadband incident light is supplied to propagatethrough a particular core fiber (block 600). Unless discharged, upon theincident light reaching a sensor of a distributed array of sensorsmeasuring strain on a particular core fiber, light of a prescribedspectral width associated with the first sensor is to be reflected backto an optical receiver within a console (blocks 605-610). Herein, thesensor alters characteristics of the reflected light signal to identifythe type and degree of strain on the particular core fiber as measuredby the first sensor (blocks 615-620). According to one embodiment of thedisclosure, the alteration in characteristics of the reflected lightsignal may signify a change (shift) in the wavelength of the reflectedlight signal from the wavelength of the incident light signal associatedwith the prescribed spectral width. The sensor returns the reflectedlight signal over the core fiber and the remaining spectrum of theincident light continues propagation through the core fiber toward adistal end of the catheter tubing (blocks 625-630). The remainingspectrum of the incident light may encounter other sensors of thedistributed array of sensors, where each of these sensors would operateas set forth in blocks 605-630 until the last sensor of the distributedarray of sensors returns the reflected light signal associated with itsassigned spectral width and the remaining spectrum is discharged asillumination.

Referring now to FIG. 6B, during operation, multiple reflected lightsignals are returned to the console from each of the plurality of corefibers residing within the corresponding plurality of micro-lumensformed within a catheter, such as the catheter of FIG. 1B. Inparticular, the optical receiver receives reflected light signals fromthe distributed arrays of sensors located on the center core fiber andthe outer core fibers and translates the reflected light signals intoreflection data, namely electrical signals representative of thereflected light signals including wavelength shifts caused by strain(blocks 650-655). The reflection data classification logic is configuredto identify which core fibers pertain to which reflection data andsegregate reflection data provided from reflected light signalspertaining to a particular measurement region (or similar spectralwidth) into analysis groups (block 660-665).

Each analysis group of reflection data is provided to shape sensinglogic for analytics (block 670). Herein, the shape sensing logiccompares wavelength shifts at each outer core fiber with the wavelengthshift at the center core fiber positioned along central axis andoperating as a neutral axis of bending (block 675). From theseanalytics, on all analytic groups (e.g., reflected light signals fromsensors in all or most of the core fibers), the shape sensing logic maydetermine the shape the core fibers have taken in three-dimensionalspace, from which the shape sensing logic can determine the currentphysical state of the catheter in three-dimension space (blocks680-685).

Referring to FIG. 7, an exemplary embodiment of the medical instrumentmonitoring system of FIG. 1A during operation and insertion of thecatheter into a patient are shown in accordance with some embodiments.Herein, the catheter 195 generally includes integrated tubing with aproximal portion 720 that generally remains exterior to the patient 700and a distal portion 730 that generally resides within the patientvasculature after placement is complete, where the catheter 195 entersthe vasculature at insertion site 710. The stylet 120 may be advancedthrough the catheter 195 to a desired position within the patientvasculature such that a distal end (or tip) 735 of the stylet 120 (andhence a distal end of the catheter 195) is proximate the patient'sheart, such as in the lower one-third (⅓) portion of the Superior VenaCava (“SVC”) for example. For this embodiment, various instruments maybe placed at the distal end 735 of the stylet 120 and/or the catheter195 to measure pressure of blood in a certain heart chamber and in theblood vessels, view an interior of blood vessels, or the like.

The console connector 133 enables the stylet 120 to be operablyconnected to the console 110 via the interconnect 145 (FIG. 1A). Herein,the connector 146 is configured to engage (mate) with the consoleconnector 133 to allow for the propagation of light between the console110 and the stylet assembly 119 (particularly the stylet 120) as well asthe propagation of electrical signals from the stylet 120 to the console110.

Referring now to FIGS. 8A-8C, cross-sectional views of a medicalinstrument disposed within a vessel where a balloon extends from adistal end of the medical instrument configured to deploy a stent withinthe vessel are shown in accordance with some embodiments. Referringspecifically to FIG. 8A, the medical instrument may comprise acombination of a catheter 802 and an inflatable balloon 804, where theballoon 804 extends from a distal end of the catheter 802. Thedeployable medical device may comprise a stent 806 that surrounds theballoon 804 during advancement of both through a patient vasculature.Further, an optical fiber 808 may extend along the length of thecatheter 802 and be detachably coupled to the stent 806. As shown, themedical instrument and the medical device may be advanced through thevessel 800 such that the stent 806 is located within a narrow portion801, i.e., a narrow or weak portion of an artery.

Referring to FIG. 8B, when the balloon 804 is inflated in order todeploy the stent 806, strain is asserted on the optical fiber 808 andthe sensors of the optical fiber 808 detect such strain. Concurrently, aconsole, e.g., the console 110 of FIG. 1, may be coupled to a proximalend of each of the catheter 802 and the optical fiber 808. A lightsource of the console 110 is configured to transmit an incident lightsignal, which propagates distally along the optical fiber 808 toward theballoon 804 and the stent 806. The sensors of the optical fiber 808reflect light having certain wavelengths back to the console 110, wherethe reflected light indicates the strain detected by the sensors. Basedon the reflected light, logic of the console 110 determines deploymentinformation pertaining to the stent 806. Referring now to FIG. 8C, theoptical fiber 808 may be detached from the stent 806 such that the stent806 remain within the patient vasculature while the catheter 802, theballoon 804 and the optical fiber 808 are withdrawn.

Referring to FIG. 8D, a detailed view of the stent 806 including achannel, groove or lumen 810 having the optical fiber 808 displacedwithin the channel, groove or lumen 810 is shown in accordance with someembodiments. In particular, a groove or channel 810 may be formed in aportion of the stent 806 such that the optical fiber 808 may rest withinthe channel, groove or lumen 810 during advancement of the catheter 802,balloon 804 and stent 806 within a patient vasculature and deployment ofthe stent 806. The optical fiber 808 may be retracted followingdeployment of the stent 806, which may be configured to remain withinthe vasculature. In some embodiments, a weak adhesive may be used tosecure a portion of the optical fiber 808 to the stent 806, specificallywithin the channel, groove or lumen 810 such that a force (such as apull from the proximal direction) may detach the optical fiber 808 fromthe stent 806.

Referring to FIG. 9A, a perspective view of a medical instrument havinga balloon extending from a distal end where an optical fiber extendsalong a length of the medical instrument and is detachably coupled tothe balloon in a first configuration is shown in accordance with someembodiments. As illustrated in FIG. 9A, the medical instrument maycomprise a catheter 900 and the deployable medical device may comprisean inflatable balloon 902 that extends from a distal end of the catheter900. In such an embodiment, an optical fiber 904 may extend along thelength of the catheter 900 and be coupled to the balloon 904 in one ofvarious configurations. FIG. 9A illustrates one exemplary embodiment inwhich a plurality of optical fibers (or a plurality of core fibers of asingle optical fiber) extend distally across the length of the balloon902.

In some embodiments, the optical fiber 904 may be permanently adhered tothe outer surface of the balloon 902. In other embodiments, the opticalfiber 904 may be encapsulated or inlayed within a material forming theballoon 902. For example, the balloon 902 may be formed using aplurality of layers of material such that the optical fiber 904 isinlayed between layers. In yet other embodiments, the optical fiber 904may wrapped around the balloon 902 in a coiled manner.

When the balloon is deployed (i.e., inflated), strain is asserted on theoptical fiber(s) 904 and the sensors of the optical fiber(s) 904 detectsuch strain. Concurrently, a console, e.g., the console 110, coupled toa proximal end of each of the catheter 900 and the optical fiber(s) 904transmits an incident light signal, which propagates distally along theoptical fibers(s) 904 toward the balloon 902. The sensors of the opticalfiber(s) 904 reflect light having certain wavelengths back to theconsole indicating the strain detected by the sensors. Based on thereflected light, logic of the console determines deployment information.

Referring to FIG. 9B, a perspective view of the medical instrument ofFIG. 9A where the optical fiber extends along a length of the medicalinstrument and is detachably coupled to the balloon in a secondconfiguration is shown in accordance with some embodiments. Asillustrated in FIG. 9B, the medical instrument comprises the catheter900 and the deployable medical device comprises the inflatable balloon902. In such an embodiment, an optical fiber 904 may extend along thelength of the catheter 900 and be coupled to the balloon 904 in one ofvarious configurations. FIG. 9B illustrates a second exemplaryembodiment in which the optical fiber 904 wraps around the balloon 902in a spiral manner extending from distally across the length of theballoon 902.

Referring to FIG. 10A, a perspective view of a medical instrument havinga balloon extending from a distal end where an optical fiber extendsalong the length of the medical instrument and is detachably coupled toan implantable valve disposed around the balloon is shown in accordancewith some embodiments. As illustrated in FIG. 10A, the medicalinstrument may comprise a combination of a catheter 1000, and aguidewire 1002 and an inflatable balloon 1004 that each extend from adistal end of the catheter 1000, and the deployable medical device maycomprise an implantable valve that is disposed is a position surroundingthe balloon 1004 during advancement of the medical instrument and themedical device through a patient vasculature. In such an embodiment, anoptical fiber 1008 may extend along the length of the catheter 1000 andbe detachably coupled to the implantable valve 1006. Although not shownin FIG. 10A, a plurality of optical fibers (or a plurality of corefibers of an optical fiber) may be utilized and be detachably coupled tothe implantable valve. For instance, each of a plurality of core fibersmay detachably couple to the implantable valve such that deployment ofthe implantable valve asserts strain on the core fiber.

Specifically, when the balloon 1004 is inflated in order to deploy theimplantable valve 1006, strain is asserted on the optical fiber(s) 1008and the sensors of the optical fiber(s) 1008 detect such strain.Concurrently, a console, e.g., the console 110, coupled to a proximalend of each of the catheter 1000 and the optical fiber(s) 1008 transmitsan incident light signal, which propagates distally along the opticalfibers(s) 1008 toward the implantable valve 1006. The sensors of theoptical fiber(s) 1008 reflect light having certain wavelengths back tothe console indicating the strain detected by the sensors. Based on thereflected light, logic of the console determines deployment information.

Referring to FIG. 10B, a cross-sectional view of the medical instrument,the balloon and the implantable valve of FIG. 10A disposed within apatient body is shown in accordance with some embodiments. FIG. 10Billustrates the medical instrument and the medical of FIG. 10A duringthe implantation process within a patient vasculature. As one example,the implantation process may be a transcatheter aortic valve replacement(TAVR) or a transcatheter aortic valve implantation (TAVI). In such anexample, the implantable valve 1006 may be a fully collapsiblereplacement valve that is delivered to a valve site through the catheter1000.

As illustrated in FIG. 10B, the implantable valve 1006 is positionedwithin the vasculature to be implanted at the aortic valve 1012. Theballoon 1004 may pass through the left atrium 1014, through the aorticvalve 1012 and partially enter the aorta 1010. The left atrium 1016 isalso illustrated in FIG. 10B. During implantation, the balloon 1004 isinflated and the implantable valve 1006 binds or adheres to the aorticvalve 1012. During deployment, strain is asserted on the opticalfiber(s) 1008 as the shape of the implantable valve 1006 changes due tothe inflation of the balloon 1004. Such strain is detected and measuredby sensors of the optical fiber(s) 1008, the incident light reflected bythe sensors indicates the strain, and thus, the deployment information.

Following implantation of the valve 1006, the balloon 1004 may bedeflated and the optical fibers(s) 1008 detached from the valve 1006such that the medical instrument including the optical fibers 1008 maybe withdrawn from the patient vasculature.

In some embodiments, the optical fiber(s) 1008 may each be disposedwithin a channel, tube or groove within the structure of the implantablevalve 1006 such that, following deployment, the optical fiber(s) 1008may be retracted. Referring to FIG. 10C, one embodiment of theimplantable valve 1006 is shown including a channel, groove or lumen1018 in which the optical fiber 1008 is disposed. In one embodiment, thechannel, groove or lumen 1018 is formed within the leaflet(s) of theimplantable valve 1006. However, alternative placement of the channel,groove or lumen 1018 have been contemplated and should be understood tobe part of this disclosure. In addition, as an optional feature, thedistal end of the optical fiber 1008 may include a hooked or curveddistal portion 1009, where the curved distal portion 1009 hooks to a lipof the channel, groove or lumen 1018 in order to provide a mechanism tokeep the optical fiber 1008 from slipping distally out of the channel,groove or lumen 1018 during advancement through a vasculature. In suchembodiments, a force (such as a pull from the proximal direction) maycause the hook or curve to deform and retract through the channel,groove or lumen 1018. In some embodiments, a weak adhesive may be usedto secure a portion of the optical fiber 1008 to the implantable valve1006, specifically within the channel, groove or lumen 1018 such that aforce (such as a pull from the proximal direction) may detach theoptical fiber 1008 from the implantable valve 1006. In some embodiments,the channel, groove or lumen 1018 may be a fully enclosed lumen as shownin FIG. 10C.

Referring to FIG. 11A, a perspective view of an implantable valvedetachably coupled with a plurality of optical fibers is shown inaccordance with some embodiments. FIG. 11A illustrates one embodiment inwhich a plurality of optical fibers (of a plurality of cores fibers)1102 are detachably coupled with leaflets of an artificial valve 1100.

Referring to FIG. 11B, a cross-sectional view of the implantable valveof FIG. 11A disposed within a vessel is shown in accordance with someembodiments. Specifically, the valve 1100 is shown deployed within avessel 1104. Further, FIG. 11B illustrates the optical fiber(s) 1102detachably coupled to leaflets of the valve 1100. The optical fiber(s)1102 may remain attached to the leaflets following deployment of thevalve 1100 in order to obtain deployment information, and specifically,as the leaflets move between positions (e.g., first and secondpositions, open and closed positions, etc.), strain is asserted on theoptical fiber(s) 1102. As optical fiber(s) 1102 detect the strain, thesensors reflected light that indicates the strain, and thus, themovement of the leaflets. As a result, the operating status of valve1100 can be determined (e.g., whether the valve 1100 properlyopens/closes).

Referring to FIG. 12A, a perspective view of a medical instrumentdeploying a coil where an optical fiber is detachably coupled to thecoil is shown in accordance with some embodiments. According to theillustration of FIG. 12A, the medical instrument may comprise a catheter1200 and the deployable medical device may comprise either one or morecoils 1202. Further, one or more optical fiber(s) 1204 may extend alongthe length of the catheter 1200 such that an optical fiber 1204 may bedetachably coupled to each of one or more coils 1202 that are deployed.When a coil 1202 is deployed (e.g., released from the catheter 1200),strain is asserted on the optical fiber 1204 as the coil 1202 twists andturns such that the sensors of the optical fiber 1204 detect suchstrain. Deployment information pertaining to deployment of the coil 1202(i.e., the shape of the coil 1202) is obtained. Following deployment ofthe coil 1202 and after the strain is detected such that reflectedincident light indicates the deployment information, the optical fiber1204 may be detached from the coil 1202 and withdrawn from the patientvasculature.

Referring to FIG. 12B, a cross-sectional view of the medical instrumentof FIG. 12A deploying a coil within an aneurysm where an optical fiberis detachably coupled to the coil is shown in accordance with someembodiments. The embodiment illustrated in FIG. 12B shows the catheter1200 advanced through the patient vasculature to a location within anartery 1206 at which an aneurysm 1208 has occurred. As discussed abovewith respect to FIG. 12A, the catheter 1200 may deploy a coil 1204 suchthat an optical fiber 1204 detachably couples to the coil 1202 in orderto obtain deployment information (e.g., a location of the deployment, astatus of the deployment, measurements of the medical device in itsdeployed state, and/or a shape of the deployed medical device).

Additionally, FIG. 12B illustrates an instance in which a stent 1210 maybe deployed at the opening of the aneurysm 1208 in order to prevent thecoil 1202 from exiting the aneurysm 1208. In particular, the stent 1210may be deployed in a similar manner as discussed above with respect toFIGS. 8A-8C (e.g., one or more optical fibers may be detachably coupledto the stent 1210 in order to obtain deployment information pertainingto the stent 1210). In such an instance, the stent 1210 may be deployedand the corresponding optical fibers withdrawn prior to deployment ofthe coil 1202. In some embodiments, the catheter 1200 may be utilizedfor deployment of both the stent 1210 and the coil 1202.

Referring to FIG. 12C, an illustration of a portion of a coil in adeployed state including a groove in which an optical fiber rests isshown in accordance with some embodiments. As illustrated, an opticalfiber 1204 may be disposed within a channel, tube or groove 1212 withinthe coil 1202 such that, following deployment, the optical fiber 1204may be retracted. In some particular embodiments, the opening of thechannel or groove 1212 may have a smaller diameter than a diameter ofthe largest portion of the channel or groove 1212 (e.g., the channel orgroove 1212 may narrow toward the opening in an effort to secure theoptical fiber 1204 within). In some embodiments, a weak adhesive may beused to secure a portion of the optical fiber 1204 to the coil 1202,specifically within the groove or channel 1212 such that a force (suchas a pull from the proximal direction) may detach the optical fiber 1204from the coil 1202. Referring to FIG. 12D, the coil 1202 may, in someembodiments, include a lumen that encloses or encapsulates the opticalfiber 1204.

Referring to FIG. 13 is a perspective view of a deployable filterdetachably coupled to an optical fiber is shown in accordance with someembodiments. As illustrated in FIG. 13, the medical instrument maycomprise a catheter 1300 and the deployable medical device may comprisea filter 1302, such as an inferior vena cava (IVC) filter. In such anembodiment, an optical fiber 1304 may extend along the length of thecatheter 1300 and be coupled to the filter 1304 in one of variousconfigurations. FIG. 13 illustrates one exemplary embodiment in which anoptical fiber extends from a proximal end to a distal end of the filter1302. However, it should be understood that a plurality of opticalfibers (or a plurality of core fibers) may extend along the length ofthe catheter 1300 and be detachably coupled to the filter 1302. As themedical device (e.g., the filter 1302) is deployed (e.g., detached fromthe catheter 1300), strain is asserted on the optical fiber(s) 1304 asthe filter 1302 expands and the sensors of the optical fiber(s) 1304detect such strain. Concurrently, a console, e.g., the console 110,coupled to a proximal end of each of the catheter 1300 and the opticalfiber(s) 1304 transmits an incident light signal, which propagatesdistally along the optical fibers(s) 1304 toward the filter 1302. Thesensors of the optical fiber(s) 1304 reflect light having certainwavelengths back to the console indicating the strain detected by thesensors. Based on the reflected light, logic of the console determinesdeployment information.

FIG. 13 may illustrate the filter 1302 being partially deployed withoutshowing the IVC or other vein for purposes of clarity. However, itshould be understood that such deployment would take place in a vesselsuch as a vein.

Referring to FIG. 14, an exemplary embodiment of the console of FIG. 1Bcoupled to a medical instrument and a medical device during operation todeploy the medical device into a patient is shown in accordance withsome embodiments. Herein, the catheter 802 may include integrated tubing(as with the catheter 130 discussed above) with a proximal portion thatgenerally remains exterior to the patient and a distal portion thatgenerally resides within the patient vasculature after placement iscomplete via an entry site. The catheter 802 may be advanced to adesired position within the patient vasculature such as to a weakened ornarrowed portion of a vessel 1400. As discussed with respect to FIGS.8A-8C, a medical instrument, e.g., the catheter 802 in combination withan inflatable balloon 804, may be configured to deploy a medical device(e.g., a stent 806). Further, an optical fiber 808 may extend the lengthof the catheter 802 and be detachably coupled to the stent 806 such thatthe optical fiber 808 is configured to detect strain asserted on theoptical fiber 808 as a result of the inflation of the balloon 804, whichhas the purpose of deploying the stent 806.

During advancement through a patient vasculature, the optical fiber 808receives incident light 155 from the console 110 via optical fiber(s)147 within the interconnect 145, where the incident light 155 propagatesalong the optical fiber 808. Further, the optical fiber 808 may returnthe reflected light signals 150 to the optical logic 180 within theconsole 110 over the interconnect 145. In a similar as that describedabove, the physical state each of the catheter 802, the balloon 804 andthe stent 806 may be ascertained based on analytics of the wavelengthshifts of the reflected light signals 150. Additionally, in someembodiments (dependent on the deployable medical device), certainmeasurements within the vessel may be ascertained based on the analyticsof the wavelength shifts of the reflected light signals 150. Forexample, the diameter of the vessel 1400 may be ascertained as impliedby the diameter of the stent 806.

Further, FIG. 14 illustrates a generated display screen 1402 rendered onthe display 170. The generated display screen 1402 may illustrates animage representing the advancement and/or deployment of the medicaldevice (e.g., the stent 806). For instance, as the shape sensing logic194 performs analyses on the reflected light signals and determines adiameter of the stent 806 (and/or other deployment information), thegenerated display screen 1402 may be altered in real-time to illustratethe sizing of the stent 806. It should be understood that the scale ofthe illustration may vary from that of the actual sizing of the stent806. In some embodiments (and/or received user input), an expectedsizing of the stent 806 may be imposed on the generated display screen1402, which may serve to enable a clinician to track the progress of thedeployment of the stent 806. Similarly, user input may be received thatindicates an expected sizing of the vessel 1400 upon completion of thedeployment of the stent 806. In some embodiments, such information maybe stored by the console 110 in one or more datastores (not shown).Further, the generated display screen 1402 includes a display of metricsof the deployment information, e.g., the diameter of the stent 806(“D=25 mm”).

Although FIG. 14 illustrates the deployment of the stent 806 and avisualization thereof, it should be understood that, based on thedisclosure above, similar generated display screens may be rendered formedical devices other than a stent. For example, such generated displayscreens may be generated and rendered for the deployment of all medicaldevices discussed above such as a balloon, a valve, a filter, etc. Insome embodiments, various images of the medical devices may be stored bythe console and utilized to render the generated display screens 1402.For instance, when the console 110 receives data indicating that themedical device to be deployed is a stent, the generation of the displayscreen 1402 may utilize a stored image of a stent where the shape andsizing of the rendered stent is based on the reflected light signals.

While some particular embodiments have been disclosed herein, and whilethe particular embodiments have been disclosed in some detail, it is notthe intention for the particular embodiments to limit the scope of theconcepts provided herein. Additional adaptations and/or modificationscan appear to those of ordinary skill in the art, and, in broaderaspects, these adaptations and/or modifications are encompassed as well.Accordingly, departures may be made from the particular embodimentsdisclosed herein without departing from the scope of the conceptsprovided herein.

1. A medical instrument system for inserting a medical instrument withina patient body, the system comprising: the medical instrument comprisingan optical fiber having one or more of core fibers; and a consoleincluding one or more processors and a non-transitory computer-readablemedium having stored thereon logic, when executed by the one or moreprocessors, causes operations including: providing an incident lightsignal to the optical fiber, where the optical fiber is coupled to adeployable medical device, receiving a reflected light signal of theincident light, and processing the reflected light signal to determinedeployment information pertaining to deployment of the deployablemedical device.
 2. The system of claim 1, wherein each of the one ormore core fibers includes a plurality of sensors distributed along alongitudinal length of a corresponding core fiber and each sensor of theplurality of sensors is configured to (i) reflect a light signal of adifferent spectral width based on received incident light, and (ii)change a characteristic of the reflected light signal for use indetermining a physical state of the optical fiber.
 3. The system ofclaim 1, wherein the deployment information includes at least one of alocation of the deployment, a status of the deployment, measurements ofthe deployable medical device in a deployed state or a shape of thedeployed medical device.
 4. The system of claim 1, wherein the opticalfiber is a multi-core optical fiber including a plurality of corefibers, and wherein the incident light propagates along a first corefiber and the reflect light signal propagates along a second core fiber.5. The system of claim 1, wherein the logic, when executed by the one ormore processors, causes further operations including generating avisualization of representing the deployable medical device within thepatient body in a non-deployed state and in a deployed state.
 6. Thesystem of claim 1, wherein the logic, when executed by the one or moreprocessors, causes further operations including generating a displayindicating the location of the distal tip of the optical fiber withinthe patient body.
 7. The system of claim 1, wherein the medicalinstrument is one of an introducer wire, a guidewire, a stylet, a styletwithin a needle, a needle with the optical fiber inlayed into a cannulaof the needle or a catheter with the optical fiber inlayed into one ormore walls of the catheter.
 8. The system of claim 1, wherein themedical device is one of a balloon, a filter, a stent or a valve.
 9. Thesystem of claim 1, wherein the medical device is a stent, and whereinthe logic, when executed by the one or more processors, causes furtheroperations including determining a diameter of the stent in a deployedstate.
 10. The system of claim 1, wherein the optical fiber is disposedwithin a groove, channel or lumen of the medical device duringadvancement of the medical device within the patient body.
 11. A methodfor placing a medical instrument into a body of a patient, the methodcomprising: providing an incident light signal to the optical fiber,where the optical fiber is coupled to a deployable medical device,receiving a reflected light signal of the incident light, and processingthe reflected light signal to determine deployment informationpertaining to deployment of the deployable medical device.
 12. Themethod of claim 11, wherein each of the one or more core fibers includesa plurality of sensors distributed along a longitudinal length of acorresponding core fiber and each sensor of the plurality of sensors isconfigured to (i) reflect a light signal of a different spectral widthbased on received incident light, and (ii) change a characteristic ofthe reflected light signal for use in determining a physical state ofthe optical fiber.
 13. The method of claim 11, wherein the deploymentinformation includes at least one of a location of the deployment, astatus of the deployment, measurements of the deployable medical devicein a deployed state or a shape of the deployed medical device.
 14. Themethod of claim 11, wherein the optical fiber is a multi-core opticalfiber including a plurality of core fibers, and wherein the incidentlight propagates along a first core fiber and the reflect light signalpropagates along a second core fiber.
 15. The method of claim 11,wherein the logic, when executed by the one or more processors, causesfurther operations including generating a visualization of representingthe deployable medical device within the patient body in a non-deployedstate and in a deployed state.
 16. The method of claim 11, wherein thelogic, when executed by the one or more processors, causes furtheroperations including generating a display indicating the location of thedistal tip of the optical fiber within the patient body.
 17. The methodof claim 11, wherein the medical instrument is one of an introducerwire, a guidewire, a stylet, a stylet within a needle, a needle with theoptical fiber inlayed into a cannula of the needle or a catheter withthe optical fiber inlayed into one or more walls of the catheter. 18.The method of claim 11, wherein the medical device is one of a balloon,a filter, a stent or a valve.
 19. The method of claim 11, wherein themedical device is a stent, and wherein the logic, when executed by theone or more processors, causes further operations including determininga diameter of the stent in a deployed state.
 20. The method of claim 11,wherein the optical fiber is disposed within a groove, channel or lumenof the medical device during advancement of the medical device withinthe patient body. 21-30. (canceled)